Identity
- Trade Name
- NvisionVLE Inflation Kit FDA UDI
- Generic Name
- Catheter/overtube balloon inflator, single-use FDA UDI
- Model / Reference
- 96101-60 FDA UDI
Identifiers
- Catalog Number
- 96101-60 FDA UDI
- Primary DI / UDI-DI
- 00859591006232 FDA UDI
- 510(k) Number
- K143678 FDA UDI
- FDA Product Code
- NQQ FDA UDI
- GMDN Term
- Catheter/overtube balloon inflator, single-use FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 892.1560 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Ethylene Oxide FDA UDI
Category: Catheter/overtube balloon inflator, single-use
NvisionVLE Inflation Kit by Ninepoint Medical, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K143678 also covers:
- NvisionVLE Imaging Console — NINEPOINT MEDICAL, INC.
- NvisionVLE Imaging Console Refurbished — NINEPOINT MEDICAL, INC.
- NvisionVLE Imaging Probe 14mm — NINEPOINT MEDICAL, INC.
- NvisionVLE Imaging Probe 14mm Clinical — NINEPOINT MEDICAL, INC.
- NvisionVLE Imaging Probe 17mm — NINEPOINT MEDICAL, INC.
- NvisionVLE Imaging Probe 17mm Clinical — NINEPOINT MEDICAL, INC.
- NvisionVLE Imaging Probe 20mm — NINEPOINT MEDICAL, INC.
- NvisionVLE Imaging Probe 20mm Clinical — NINEPOINT MEDICAL, INC.
- NvisionVLE Low Profile Imaging Probe, 0mm Working Distance — NINEPOINT MEDICAL, INC.
- NvisionVLE Low Profile Imaging Probe, 14mm Working Distance — NINEPOINT MEDICAL, INC.
- NvisionVLE Low Profile Imaging Probe, 20mm Working Distance — NINEPOINT MEDICAL, INC.
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Ninepoint Medical, Inc.
Sources (1)
- FDA UDI a1983968-e861-47b7-a17c-202b54d02b55 35 fields · synced Jun 1, 2026